Duties & Responsibilities:
- Understand the process requirement of all processes and equipment in the production area.
- Responsible for maintaining process work instructions associated with all manufacturing processes such as manufacturing assembly and in-process acceptance procedures.
- Collaborate with Engineers in developing and implementing Visual Aids and Physical Samples on critical steps of the process to indicate proper acceptance criteria.
- Train manufacturing staff to release work instructions.
- Execute Process Validation Protocols and/or Transference Plans and assist Engineers in generating test reports.
- Maintain and help Engineers improve process risk assessments and pFMEA.
- Lead and support investigation, disposition, and corrective action of non-conforming materials.
- Identify areas for improvement while maintaining high levels of manufacturing and product quality.
- Sustain the statistical process controls (SPC) for manufacturing operations.
- Ensure cost reduction and process improvement programs.
Minimum & Preferred Qualifications and Experience:
Minimum Qualifications:
- Experience with optical/electro-mechanical assembly and testing.
- Experience in modern manufacturing principles and techniques.
- Working knowledge of statistical techniques (e.g., DOE, FMEA, SPC).
- Experience in process automation, verification, and validation.
- Excellent communication skills and technical writing abilities.
- Excellent conceptual, analytical, and problem-solving abilities.
- Excellent computer skills – CAD software, word processing, and spreadsheets.
- Ability to work effectively in cross-functional teams.
Preferred Qualifications:
- Technical experience working in a high-volume manufacturing environment.
- Experience in the application of statistical process controls in a manufacturing environment.
- Experience in manual, semi-automated, and automation processes, verification, and validation.
- Hands-on skills with electro-mechanical troubleshooting and diagnostics.
- Good conceptual, analytical, and problem-solving abilities.
- Good computer skills - CAD, word processing, and spreadsheets.
- Ability to be part of a team and adept in building and leading teams.
- Knowledge and experience in FDA QSR requirements and preferably ISO-13485 requirements.
- Experience with planning and executing process validations and managing process risk assessment.
- Knowledge of developing and executing savings projects through lean manufacturing techniques.
- Good English communication skills, both verbal and written, and the ability to effectively interface with Research and Development, Quality Assurance, and other functional groups in the organization.
Education:
- Diploma and B.S. in Mechanical Engineering, Electrical Engineering, Manufacturing, Mechatronics, or Industrial Engineering.